Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01335477
First received: April 13, 2011
Last updated: January 29, 2015
Last verified: January 2015
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Pulmonary Fibrosis
Interventions: Drug: placebo
Drug: BIBF 1120

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Oral administration of Placebo matching nintedanib soft gelatine capsules
Nintedanib 150 mg Bid

Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).

Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.


Participant Flow:   Overall Study
    Placebo     Nintedanib 150 mg Bid  
STARTED     220     331  
COMPLETED     179     272  
NOT COMPLETED     41     59  
Adverse Event                 30                 42  
Non compliant with protocol                 0                 2  
Lost to Follow-up                 1                 2  
Consent withdrawn, not due to AE                 7                 9  
Not treated                 1                 2  
Reason other than those stated above                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set (TS): The TS consisted of randomized patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Reporting Groups
  Description
Placebo Oral administration of Placebo matching nintedanib soft gelatine capsules
Nintedanib 150 mg Bid

Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).

Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.

Total Total of all reporting groups

Baseline Measures
    Placebo     Nintedanib 150 mg Bid     Total  
Number of Participants  
[units: participants]
  219     329     548  
Age  
[units: years]
Mean (Standard Deviation)
  67.1  (7.5)     66.4  (7.9)     66.6  (7.8)  
Gender  
[units: participants]
     
Female     48     73     121  
Male     171     256     427  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.   [ Time Frame: 52 weeks ]

2.  Secondary:   Change From Baseline in Saint George’s Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]

3.  Secondary:   Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation   [ Time Frame: 52 weeks ]

4.  Secondary:   Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks   [ Time Frame: Baseline and 52 weeks ]

5.  Secondary:   Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks   [ Time Frame: Baseline and 52 weeks ]

6.  Secondary:   Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks   [ Time Frame: Baseline and 52 weeks ]

7.  Secondary:   Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks   [ Time Frame: Baseline and 52 weeks ]

8.  Secondary:   Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold   [ Time Frame: Baseline and 52 weeks ]

9.  Secondary:   Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold   [ Time Frame: Baseline and 52 weeks ]

10.  Secondary:   FVC Responders Using 10% Threshold at 52 Weeks   [ Time Frame: 52 weeks ]

11.  Secondary:   Proportion of FVC Responders Using 5% Threshold at 52 Weeks   [ Time Frame: 52 weeks ]

12.  Secondary:   Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)   [ Time Frame: baseline and 52 weeks ]

13.  Secondary:   Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)   [ Time Frame: baseline and 52 weeks ]

14.  Secondary:   Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)   [ Time Frame: baseline and 52 weeks ]

15.  Secondary:   Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)   [ Time Frame: baseline and 52 weeks ]

16.  Secondary:   Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)   [ Time Frame: baseline and 52 weeks ]

17.  Secondary:   Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)   [ Time Frame: baseline and 52 weeks ]

18.  Secondary:   Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)   [ Time Frame: baseline and 52 weeks ]

19.  Secondary:   Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)   [ Time Frame: baseline and 52 weeks ]

20.  Secondary:   Proportion of Patient’s Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)   [ Time Frame: 52 weeks ]

21.  Secondary:   Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)   [ Time Frame: baseline, 12 weeks, 24 weeks and 52 weeks ]

22.  Secondary:   Risk of an Acute IPF Exacerbation Over 52 Weeks   [ Time Frame: 52 weeks ]

23.  Secondary:   Time to Death Over 52 Weeks   [ Time Frame: 52 weeks ]

24.  Secondary:   Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)   [ Time Frame: 52 weeks ]

25.  Secondary:   Time to On-treatment Death   [ Time Frame: 52 weeks ]

26.  Secondary:   Time to Death or Lung Transplant Over 52 Weeks   [ Time Frame: 52 weeks ]

27.  Secondary:   Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks 52 Weeks.   [ Time Frame: 52 weeks ]

28.  Secondary:   Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks   [ Time Frame: baseline and 52 weeks ]

29.  Secondary:   Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks   [ Time Frame: baseline and 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01335477     History of Changes
Other Study ID Numbers: 1199.34, 2010-024252-29
Study First Received: April 13, 2011
Results First Received: November 14, 2014
Last Updated: January 29, 2015
Health Authority: Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Drugs Controller General of India
Japan: Ministry of Health, Labor and Welfare
Mexico: Ministry of Health
Netherlands: Central Committee Research Involving Human Subjects
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United States: Food and Drug Administration